Johnson & Johnson ($JNJ) scored an early FDA approval for its "breakthrough" blockbuster contender daratumumab, earning a swift OK as a new treatment for multiple myeloma four months ahead of the PDUFA date. The drug will be marketed as Darzalex. The pharma giant signed up for a $1.1 billion deal to gain rights to the drug from Genmab, which also benefits considerably from today's marketing approval. An early winner of breakthrough drug status at the FDA, J&J will now get a jump on Bristol-Myers Squibb ($BMY) and AbbVie ($ABBV), which have another "breakthrough" multiple myeloma drug, elotuzumab, in late-stage development. The approval comes hard on the heels of another early cancer drug approval, with AstraZeneca ($AZN) picking up an early OK on AZD9291, to be sold as Tagrisso. The FDA, and particularly the oncology group inside the agency, have been lopping months off the approval timeline for new therapies. THIS DRUG WILL KILL KYPROLIS IN THE THIRD LINE AND THEN IN THE SECOND LINE. IT HAS A RESPONSE RATE OF 29%-36% IN THE THIRD LINE SETTING WHERE KYPROLIS ONLY HAD 23% AND GOT APPROVAL. THIS DRUG IN COMBO WITH KYPROLIS EXPLAINS WHY JNJ IS INTERESTED IN AMGEN. "Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies." Daratumumab is given once a week for the first two months of treatment, then the infusions wind down to once monthly in the second 6 months of the year, says a spokesperson for J&J. For the first full year--with a total of 23 doses given at a cost of $5,850 per infusion--the average monthly wholesale acquisition cost is $11,212, says J&J, or $135,550 for the first year. In year two, and any year thereafter, patients receive a total of 13 doses, for a monthly wholesale cost of $6,337, or $76,044 annually. J&J also offers programs to limit patient's out-of-pocket costs and will be offering payers discounts during price negotiations. Focusing on the group of patients getting the top dose, investigators reported in The New England Journal of Medicine last August that the drug scored an impressive 36% overall response rate among 42 patients with late-stage multiple myeloma--a step up from the 29% overall rate that was reported at ASCO earlier in the year. And two-thirds of the responder group benefited from progression-free survival after 12 months of therapy. The dose-escalating study also satisfied researchers that they would be able to use the 16-mg dose for all future studies of the drug, an IgG1k antibody that binds to CD38 on the surface of multiple myeloma cells. Daratumumab has excited a range of analysts happy to roll out multibillion-dollar projections for this drug. Kyprolis won an approval for Onyx with a 23% ORR, and then was bought out by Amgen ($AMGN), which recently scored a new combo approval for relapsed cases, looking for more of an edge in its fight to steal market share from Celgene's ($CELG) Pomalyst.
They got a higher response rate in a much more heavily pre-treated patient population from the PI. Wow - If we bought Onyx for $10B, what are the chances it becomes a $3B dollar drug to justify the price with a 3:1 ratio of Acquisition cost to peak sales? Right now, Kyprolis is at $137M in Q3 2 years post launch. If it makes $175 a qtr next year the that means its a $700M drug and needs to double to $1.4B in 2 more years (2018) and then double again to $2.8 in 2020. That's pretty aggressive since the new jNJ drug is more impressive and other MM drugs will coming to market, many of which like Venetoclax or Ibrutinib will be excelling in other hem onc conditions so physicians will be experience with them when they get MM approval. I have a feeling Amgen miscalculated the value of Kyprolis and Repatha and we will be bought out by a player who will take our assets and strip Amgen apart. The median patient age was 64 years (range: 44 to 76 years), 64% were male and 76% were Caucasian. Patients in the study had received a median of 4 prior lines of therapy. Seventy-four percent of patients had received prior ASCT. Prior therapies included bortezomib (100%), lenalidomide (95%), pomalidomide (36%) and carfilzomib (19%). At baseline, 76% of patients were refractory to the last line of treatment, 64% of patients were refractory to both, a PI and an immunomodulatory agent, and 60% of patients were refractory to alkylating agents. Overall response rate was 36% (95% CI: 21.6, 52.0%) with 1 CR and 3 VGPR. The median time to response was 1 month (range: 0.5 to 3.2 months). The median duration of response was not estimable (range: 2.2 to 13.1+ months).
Different MOA. Portfolio power play. Then can keep the Imbruvica reps from their co-promote to sell Kyprolis.
Wow their failures even had Kyprolis patiebts. I bet this would work much better in 2nd and 3rd line. Onyx reps must be shitting now.
There are very few Onyx reps left dummy. They don't care. They made their money and are either riding Amgen out to retirement or waiting for a better opportunity than Clovis(oops) and Tesaro.
The Onyx acquisition and the future of Kyprolis are a bad deal because Amgen's leadership team got greedy and turned the product over to an inexperienced commercialization team in TO and Reps who have no clue how to promote a novel oncologic therapy. The blame falls on BB, SH, TC and the "leader$#!+" in TO
They went straight for second line therapy and they are oral too! Takeda Pharmaceutical's top cancer prospect won a speedy FDA approval, wading into a crowded market for multiple myeloma treatments with hopes of duplicating the success of Velcade. The drug, ixazomib, is approved for relapsed and refractory multiple myeloma, a form of cancer that begins in the blood marrow. The nod comes just two months after the FDA accepted Takeda's application, reflecting the agency's increasing willingness to quickly approve new cancer treatments. Ixazomib, which Takeda plans to market as Ninlaro, is the third multiple myeloma drug approved this year, following Johnson & Johnson's ($JNJ) Darzalex and Novartis' ($NVS) Farydak. Like Takeda's blockbuster-selling Velcade and Amgen's ($AMGN) Kyprolis, ixazomib is a proteasome inhibitor, designed to kill tumors by cutting off the production of proteins they need to grow. But unlike those injected therapies, Takeda's new treatment is a pill, and the company believes ixazomib could reach blockbuster status by unseating some aging competitors in hematology. The drug has also showed promise in the related indication of systemic light-chain amyloidosis, which won it the FDA's coveted breakthrough-therapy designation. Ixazomib, picked up in Takeda's $8.8 billion acquisition ofMillennium Pharmaceuticals, is a key asset for the Japanese drugmaker as it restructures its global business and moves on from some clinical setbacks. Under new CEO Christophe Weber, Takeda is in the process of trimming about $1 billion from its budget and cutting 3,000 jobs around the world. Ixazomib's approval clears it for use alongside Celgene's ($CELG) Revlimid and the corticosteroid dexamethasone in multiple myeloma patients who have already undergone first-line therapy. Takeda is working through four additional Phase III studies designed to widen ixazomib's indication, testing the drug in newly diagnosed multiple myeloma and amyloidosis.
KYPROLIS DOSING: Hydrate prior to and following administration.as needed. (2.1) Premedicate with dexamethasone prior to all Cycle 1 doses and if infusion reaction symptoms develop or reappear. (2.1, 2.2) Administer intravenously as a 10 minute infusion on two consecutive days each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). (2.1, 2.2) Kyprolis is administered at a starting dose of 20 mg/m2 /day in Cycle 1 on Days 1 and 2. If tolerated, the dose should be escalated to a target dose of 27 mg/m2 /day on Day 8 of Cycle 1. NINLARO DOSING Recommended starting dose of 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle. (2.1) Dose should be taken at least one hour before or at least two hours after food. (2.1) NINLARO IS WAY EASIER TO TAKE AND THE SAME MOA. KYPROLIS DOWN!!!
Takeda Pharmaceutical Co. lost a court ruling that could shave years off the time before generic-drug versions of its top-selling cancer drug Velcade hits the market. A patent on the medicine that expires in 2022 is invalid, U.S. District Judge Gregory Sleet concluded Thursday. He agreed with generic-drug makers who said the patent for a formulation of the drug is “the inherent result of an obvious process.” The ruling means that a generic version of the medicine could enter the market when another patent expires in May 2017. How will Kyprolis make $2-$4B to justify the cost?
Kyprolis was impressive as teb only game in town. It's no longer the cool kid since the JnJ drug is better and the takeda drug is far more convenient. I bet a peak sales of 1.8B max but that's too low given the slow ramp up. Only deal was over priced. Models did not adequately factor competitive threats and now Amgen will pay for it.
Third MM drug approved this month Can Bristol-Myers Squibb And AbbVie's Empliciti Become a Top Seller? The FDA's approval of Empliciti could reshape second-line multiple myeloma treatment
when repatha stalls below expectations, when Amgen biosimilars are in court and not launching for 4-5 years, and now that Kyprolis use will be much less......Who is going to buy us? How many more layoffs will happen?
